Using BHB with CAR-T therapy for lymphoma treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the safety and tolerability of β-hydroxybutyrate (BHB) supplementation in patients undergoing treatment for large B-cell lymphoma with anti-CD19 CAR T-cells. Participants will receive oral BHB supplementation through HVMN Ketone-IQ while receiving standard CAR-T therapy. The study aims to assess whether BHB affects the gut microbiome and peripheral blood mononuclear cells (PBMCs) in this patient population.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age of 18 years or older
* History of pathologically-confirmed large B-cell lymphoma (LBCL)
* Planned treatment with a commercially available anti-CD19 CAR-T product (Yescarta or Kymriah)
* Eligible for and with adequate organ function (investigator discretion) and performance status (ECOG PS 2 or less) for standard of care, anti-CD19 CAR-T
* Not enrolled on a clinical trial of bridging therapy prior to CAR-T
* Patients must have a PET/CT scan (preferred), diagnostic CT scan, or MRI with at least one bi-dimensionally measurable lesion (≥ 1.5 cm for nodal lesions or ≥ 1cm for extra- nodal lesions in largest dimension by low-dose computerized tomography \[CT\] scan with FDG-uptake ≥ liver) documented prior to leukapheresis for CAR-T manufacturing
* Resolution of toxicities from prior therapy to a grade that does not contraindicate trial participation in the opinion of the investigator
* Can provide informed consent
* Willing to comply with all study procedures and available for the duration of the study

Exclusion Criteria:

* Subject is pregnant or breast feeding
* History of allergy to energy drinks
* History of inflammatory bowel disease
* History of type 1 diabetes mellitus or requirement for insulin
* History of chronic kidney disease with an eGFR \< 30 mL/min/1.73m2
* Additional second primary malignancy for which the subject is receiving active therapy or that will impede the ability of the investigator to assess lymphoma response

Where it's running

• Abramson Cancer Center at University of Pennsylvania
  Philadelphia, Pennsylvania, United States Recruiting

Study contacts

• Principal investigator: Elise Chong, MD — Abramson Cancer Center at the University of Pennsylvania
• Study coordinator: Brittany Koch, MPH
• Email: Brittany.Koch@pennmedicine.upenn.edu
• Phone: 215-615-4312

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• In Vivo CD19/CD20 CAR T-Cell Therapy for Relapsed or Refractory B-Cell Lymphoma

  This early-phase trial tests a one-time in vivo CAR T-cell therapy (SL1617) for people with relapsed or refractory B-cell lymphoma to see if it is safe and tolerable.

  Recruiting Phase 1 Chinese PLA General Hospital · Beijing · NCT07775508

• Radiation, Vancomycin, and CAR-T for B-Cell Lymphoma

  This trial tests if giving radiation and the antibiotic vancomycin before CAR-T cell therapy is feasible for adults with large B-cell lymphomas.

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• Predictors of response to CD19 CAR-T therapy in relapsed/refractory large B‑cell lymphoma

  This study will see if clinical features, tumor biology, and immune cell changes can predict who responds to CD19 CAR‑T therapy for relapsed/refractory large B‑cell lymphoma.

  Recruiting Fudan University · Shanghai, Shanghai Municipality · NCT07236203

• Ronde-cel versus standard CD19 CAR T‑cell therapy for relapsed or refractory large B‑cell lymphoma

  This test sees if ronde-cel, a CAR T therapy that targets both CD19 and CD20, works better than currently used CD19 CAR T therapies for adults whose large B‑cell lymphoma returned or did not respond after first‑line treatment.

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• CD5 CAR T-cell therapy for relapsed or refractory T-cell lymphoma

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  Recruiting at 3 sites Phase 1/2 Beijing GoBroad Hospital · Beijing and 2 other locations · NCT07022964

• Glofitamab plus obinutuzumab for mantle cell lymphoma after CAR‑T

  This trial tests whether the antibody drug glofitamab given with obinutuzumab can shrink or control mantle cell lymphoma that returned or didn't respond after CD19 CAR‑T therapy in adults.

  Recruiting at 11 sites Phase 2 National Cancer Institute (NCI) · Duarte, California and 10 other locations · NCT07003295

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.